Veliparib + Temozolomide for Leukemia

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Ivana Gojo

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I clinical trial is studies the side effects and best dose of giving veliparib together with temozolomide in treating patients with acute leukemia. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with temozolomide may kill more cancer cells.

Eligibility Criteria

This trial is for adults with various types of acute leukemia, including those who have relapsed or are not responding to other treatments. It's also open to older patients who can't undergo intensive chemotherapy and those with certain genetic mutations. Participants must be able to swallow pills, have no severe infections or illnesses that could interfere with the study, and agree to use contraception.

Inclusion Criteria

My leukemia has returned or didn't respond to treatment, and I've tried at least 2 TKIs without success.

My CML is in an advanced stage and I've not responded to at least 2 TKIs or have a specific resistance mutation.

I had a stem cell transplant over 60 days ago, have no graft vs. host disease, and stopped all immunosuppressive therapy over 2 weeks ago.

Exclusion Criteria

I do not have any ongoing infections that are not being treated.

I do not have any severe illnesses that would stop me from following the study's requirements.

I am HIV positive with a CD4 count over 250, not on zidovudine or stavudine.

Participant Groups

The trial is testing the combination of two drugs: Veliparib and Temozolomide. The goal is to find the safest dose that effectively treats acute leukemia by blocking enzymes cancer cells need for growth while stopping their division. This phase I trial will also look at how these drugs affect biomarkers in lab tests.

Group I: Treatment (temozolomide and veliparib) Experimental Treatment 4 Interventions

Patients receive veliparib PO QD on day 1 and twice daily on days 4-12 and temozolomide PO QD on days 3-9 of course 1. Beginning at least 30 days after the start of treatment, patients receive veliparib PO BID on days 1-8 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission receive 5 more courses in the absence of disease progression or unacceptable toxicity.

Temozolomide is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Temodal for:

• Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment
• Children from the age of three years, adolescents and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy

🇺🇸 Approved in United States as Temodar for:

• Newly diagnosed glioblastoma concomitantly with radiotherapy and subsequently as monotherapy treatment
• Newly diagnosed or refractory anaplastic astrocytoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, MD

University of Chicago Comprehensive Cancer Center Chicago, IL

University of Maryland/Greenebaum Cancer Center Baltimore, MD

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References